- Prophylaxis has been associated with fewer invasive procedures and less orthopedic surgery, hospitalization, time lost from work, and hemophilic arthropathy compared with on-demand treatment25
- Prophylaxis generally increases the number of infusions,25 so ease of use is important for patients and their families
ReFacto is the ONLY factor VIII product approved for short-term routine prophylaxis16-20*
Fewer bleeding episodes while on prophylaxis
- Prophylactic infusions with ReFacto have been shown to reduce the number of breakthrough bleeds in previously treated patients (PTPs)22,23
- PTPs studied during both on-demand and prophylaxis periods had16
- 10 bleeding episodes/year while on prophylaxis
- 25 bleeding episodes/year during on-demand periods
- PUPs studied during both on-demand and prophylaxis periods had16
- 6 bleeding episodes/year while on prophylaxis
- 11 bleeding episodes/year during on-demand periods
*The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
Results from patients (PUPs, n=45; PTPs, n=85) who had both on-demand and prophylactic periods during their time on the study. These nonrandomized trial results should be interpreted with caution, as the investigators exercised their own discretion in deciding when and in whom prophylaxis was to be initiated and terminated.
Dosing Formula
ReFacto dosing follows the standard formula16:

Required units = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
Indication ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
Important Safety Information
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As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. |
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The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto. |
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Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur. |
Please see ReFacto Prescribing Information The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.
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